California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking...

20
California’s Proposition 65: A Guidebook and Resource Legal insight. Business instinct.

Transcript of California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking...

Page 1: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

California’s Proposition 65: A Guidebook and Resource

Legal insight. Business instinct.

Page 2: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

1

Introduction

Since its enactment over 15 years ago, California’s Proposition 65 has distinguished itself

as an unusual statute that requires the business community’s careful attention. Its

distinguishing features include:

The penalty for non-compliance is $2,500 per violation per day. Because there

are no published decisions defining the term “violation” or firmly establishing the

law’s statute of limitations, plaintiffs often demand hundreds of thousands of

dollars – if not more – to settle a case.

Private citizens, as well as the Attorney General and local district attorneys, may

sue to enforce the law. A business is likely to face an environmental organization

or a “bounty-hunting” plaintiff rather than or in addition to a public prosecutor.

Private and public plaintiffs alike seek attorneys fees as well as penalties.

Proposition 65 requires very little showing from plaintiffs – and no showing of

actual harm – before the burden shifts to the defending company to show that it

has not violated the law.

Proposition 65 applies to very small levels of chemicals – levels that in some

cases are a thousand times lower than those permitted by other laws.

The California Supreme Court has said that Proposition 65 is to be construed

“broadly to accomplish [its] protective purpose.” Thus, close cases may be

decided against the regulated community.

Because it was originally enacted by the voters, Proposition 65 can be amended

only by a two-thirds vote of the legislature, and only if the amendment furthers

the general purposes of the law.

Proposition 65 claims are often combined with other pro-plaintiff statutes such as

California’s unfair competition and consumer protection laws. These complaints

become difficult to defeat on procedural grounds or on summary judgment.

Page 3: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

2

Overview

California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly

referred to as “Proposition 65.” It applies to people doing business in California,

including those who ship products into the state. The only entities exempted are

those with fewer than ten employees, governmental units, and anyone operating a

public water system.

Under Proposition 65, the State maintains a long list of chemicals that are either

carcinogens or reproductive toxicants. Many chemicals are on both lists. Basically,

Proposition 65 prohibits businesses from:

discharging listed chemicals to “sources of drinking water” in the state; or

exposing people in the state to listed chemicals without prior warning. Although not all discharges or exposures to listed chemicals are prohibited, any

potential discharge or exposure to a listed chemical should prompt a review of the

applicable regulations.

The most recent versions of the lists are contained in the Proposition 65 regulations.

Be sure to review the most current lists, which are available on the website of the

State’s Office of Environmental Health Hazard Assessment (“OEHHA”) at

www.oehha.org.

Lawsuits alleging violations of Proposition 65 frequently also include claims under

California’s unfair competition and consumer protection laws. These statutes are

some of the toughest in the country and offer plaintiffs a variety of procedural

advantages. These laws are composed of the Unfair Business Practices Act

(California Business & Professions Code § 17200); its counterpart provision on false

advertising, the False Advertising Act (California Business & Professions Code

§ 17500); and the Consumers Legal Remedies Act (California Civil Code § 1750).

Please note: This is only a general introduction to Proposition 65. It cannot provide you with legal advice that takes account of all the idiosyncrasies of your company’s products or operations or the details of the law regarding Proposition 65. If you believe your products or operations raise Proposition 65 compliance issues, you may wish to consult legal counsel.

Page 4: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

3

The List of Chemicals

Proposition 65 requires the State of California to publish and revise, at least once

each year, a list of chemicals known to the State to cause cancer or reproductive

harm. The chemicals listed trigger Proposition 65’s warning requirement and

discharge prohibition. If a chemical is not on the list, Proposition 65 does not apply.

Hundreds of chemicals are listed.

How are chemicals added to the list? A chemical is added to the Proposition 65

list if:

The State’s qualified experts review scientific studies and identify the chemical

as known to the State to cause cancer or reproductive toxicity. The State has

established a Science Advisory Board and two committees – the Carcinogen

Identification Committee and the Developmental and Reproductive Toxicant

Identification Committee – to act as its qualified experts.

OEHHA determines that an authoritative body identified by the Science Advisory

Board has formally identified the chemical as causing cancer or reproductive

harm.

OEHHA determines that a state or federal agency has formally required the

chemical to be identified or labeled as causing cancer or reproductive toxicity.

What information can I find on the list? The list provides the name of each

chemical covered by Proposition 65. In addition, the list provides a Chemical

Abstracts Service (“CAS”) registry number for each chemical and the date when the

chemical was initially listed. Given the similarity of many chemical names, the CAS

number makes it easier to verify the identity of a listed chemical. The date on the list

allows you to determine when the warning requirement and the discharge prohibition

takes (or took) effect. The warning requirement takes effect 12 months after the date

of listing; the discharge prohibition takes effect 20 months after the date of listing.

Is the list current? Chemicals are frequently added to, and sometimes removed

from, the list. Be sure to review the most current list at: www.oehha.org.

Page 5: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

4

The Discharge Prohibition

Proposition 65 prohibits businesses with 10 or more employees from knowingly

discharging or releasing a listed chemical into the environment (whether air, land or

water) where the chemical passes or probably will pass into a source of drinking

water. This prohibition initially was understood to refer to pollution of streams, lakes

and groundwater; however, the California Supreme Court, in People v. Superior

Court (American Standard), 14 Cal. 4th 294 (1996), expanded the coverage of

Proposition 65 to include devices, such as faucets and pipes that convey drinking

water for consumption, within the meaning of “source of drinking water.”

There are four primary exemptions from the discharge prohibition:

Time period after listing. The discharge prohibition does not apply to a

chemical until 20 months after the chemical is listed. California Health and Safety

Code (“HSC”) § 25249.9(a). This is not relevant for most of the over 650

chemicals already on the list, but it applies as chemicals are added to

the list.

Knowing discharge. The discharge prohibition applies only to those persons

who knowingly discharge or release a listed chemical. HSC § 25249.5.

“Knowingly” refers merely to knowledge of the discharge or release and not to

knowledge that the discharge or release violates the Proposition 65 discharge

prohibition. 22 California Code of Regulations (“CCR”) § 12102. In other words, if

you know that your company is discharging a listed chemical in any amount, the

“knowing” requirement may be satisfied.

Stormwater runoff. The regulations exempt listed chemicals in stormwater

runoff, so long as the listed chemical “is not the direct and immediate result of

the business activities conducted at the place from which the runoff flows.”

22 CCR § 12401(c). Runoff from parking lots is specifically exempted. Id.

Significant amount. There is no violation if the discharge or release will not

cause any “significant amount” of the chemical to enter any source of drinking

water and the discharge or release is in conformity with “all other laws.”

HSC § 25249.9(b).

Page 6: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

5

But the question of what constitutes a “significant amount” is quite tricky. The

statute defines the term generally to mean “any detectable amount,” but allows a

“detectable amount” to be discharged so long as it meets certain exposure criteria:

• Carcinogens. If the chemical is listed as a carcinogen, then the discharger

must be able to show that the amount of chemical entering a source of

drinking water would pose no significant risk of cancer assuming that an

individual is exposed to that amount in drinking water for a 70-year lifetime.

HSC §§ 25249.11(c), 25249.10(c); 22 CCR § 12721(c).

• Reproductive Toxicants. If the chemical is listed as a reproductive toxicant,

the amount entering a source of drinking water must be so low that, if it were

multiplied by 1,000, it would have no observable effect on an individual

exposed to that amount in drinking water. HSC §§ 25249.11(c), 25249.10(c);

22 CCR § 12801(c).

The burden is on the discharger to prove these facts, which often requires extensive

technical analysis. HSC § 25249.9. For some chemicals, the State has established

regulatory levels that do not exceed the exposure criteria. But for most chemicals it

has not. In an enforcement action, the plaintiff has the burden of proving that a listed

chemical has entered or probably will enter a source of drinking water. The

discharger then has the burden of proving that the discharge will not cause a listed

chemical to enter drinking water in a significant amount.

Page 7: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

6

The Warning Requirement

Proposition 65 prohibits businesses with 10 or more employees from knowingly and

intentionally exposing any individual in California to a listed chemical without first

giving a clear and reasonable warning.

Knowledge of the exposure. The term knowingly has the same meaning as for

the discharge prohibition. If you know that exposure to any detectable amount of

a listed chemical is occurring, that may be enough to trigger Proposition 65.

22 CCR § 12102(n). The term intentionally is not defined in the statute or in the

regulations, but exposures caused by accident, without intention or negligence,

do not violate the warning requirement.

Exemptions. All exposures to detectable amounts of listed chemicals require a

prior warning unless the exposure is specifically exempted under the statute.

There are four general exemptions:

• Time period after listing. Exposures that take place less than 12 months

after a chemical is listed are exempted. Note that this “grace period” is

shorter than the 20 months allowed under the discharge prohibition.

• Federal preemption. If federal law governs warning in a manner that

preempts state authority, then no Proposition 65 warning is required. The

courts have considered a number of claims that various federal laws preempt

Proposition 65. For the most part, the courts have held that the federal laws

in question do not preempt Proposition 65 except for the federal Occupational

Health and Safety Act and the federal Hazard Communication Standard

(“HCS”). Courts have determined that the federal HCS preempts the

Proposition 65 warning requirement as it applies to workplace exposures

except to the extent that Proposition 65 is incorporated in the State Plan

approved by the federal Occupational Safety and Health Administration

(“OSHA”).

• Out-of-state manufacturers. When OSHA approved California’s

incorporation of Proposition 65 into the State Plan by way of the California

HCS, OSHA made it clear that California cannot enforce its State Plan

against out-of-state manufacturers who produce products for use in a

California workplace. Out-of-state manufacturers are subject to the federal

HCS or, if the manufacturer is producing in an authorized state, then the

hazard communication requirements of that state’s OSHA-approved state

Page 8: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

7

plan. Nevertheless, if products are manufactured outside of California, and

then reformulated, repackaged or relabeled in California for sale within the

state, then the California formulator, packager or labeler may be deemed a

“manufacturer” for purposes of California’s HCS. A copy of the California

HCS may be found at 8 CCR § 5194.

• Exposure criteria. Exposures that meet the Proposition 65 exposure criteria

are exempted from the warning requirement. For carcinogens, this means

that the exposure will pose no significant risk of cancer. For reproductive

toxicants, it means that there will be no observable effect assuming an

exposure at 1,000 times the level in question. In order to take advantage of

this exemption, you must determine the amount of exposure that occurs as a

result of your business activities, and then determine whether the exposure

will exceed the relevant exposure criteria. If you are prepared to demonstrate

that the exposure does not exceed the relevant exposure criteria, then a

warning is not required. If you are not prepared to make such a

demonstration, then you should provide a clear and reasonable warning. Be

mindful of the fact that the Proposition 65 exposure criteria are often far more

stringent than the levels deemed acceptable by other governmental

authorities.

Clear and reasonable warnings. In order to be effective as a clear and

reasonable Proposition 65 warning, the warning must meet certain general

criteria for the method of transmission and the content of the warning message.

• The method employed to transmit the warning must be reasonably

calculated, considering the alternative methods available under the

circumstances, to make the warning message available to an individual prior

to exposure. 22 CCR § 12601(a).

• The message must clearly communicate that the chemical in question is

known to the State to cause cancer, on the one hand, or birth defects or other

reproductive harm, on the other. Id.

Safe harbor warnings. OEHHA has developed safe harbor warnings that are

deemed to be clear and reasonable. You may rely on the safe harbor warning

methods and messages, but you are not required to do so. You may develop your

own warning system so long as the warnings you convey meet the general

requirements set forth above for the warning method and the message. Be

Page 9: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

8

advised, however, that attempts to soften the warning message by the use of the

words “may contain” chemicals known to cause cancer or reproductive toxicity, or

by describing contrary data obtained in some studies, may cause the warning to

be questioned as not being “clear and reasonable.” Safe harbor warnings are

provided for three types of exposure: consumer product, occupational and

environmental, as described below.

Consumer product exposures. A consumer product exposure is one that

“results from a person’s acquisition, purchase, storage, consumption, or the

reasonably foreseeable use of a consumer good, or any exposure that results

from receiving a consumer service.” 22 CCR § 12601(b). Three methods of

transmission are deemed clear and reasonable for consumer product warnings.

They may be used alone or in combination.

• A warning that appears on a product’s label or other labeling, if it is likely that

the label will be read and understood by ordinary persons using the product.

• identification of the product at the retail outlet in a manner that provides a

warning. Identification may be through shelf labeling, signs, menus or a

combination of these.

• A system of signs, public advertising identifying the system, and toll-free

information services, or any other system that provides clear and reasonable

warnings.

To the extent practicable, warning notices, signs and labels must be provided by

the product manufacturer, producer or packager, rather than by the retail

seller. 22 CCR § 12601(b)(2). Warnings on product labels or retail signage must

be styled and placed in a manner likely to be read and understood by an ordinary

individual under customary conditions of purchase or use. Signs must be

conspicuous, and label warnings must stand out as compared with other signs,

words, designs or statements on the label. 22 CCR § 12601(b)(3).

The warning message must effectively communicate to the user that the

chemical in question is known to the State to cause cancer and/or birth defects

or other reproductive harm. The safe harbor regulations provide language for

consumer product warnings that will be deemed clear and reasonable if properly

transmitted.

Page 10: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

9

For consumer products that contain a carcinogen, the following language is provided:

WARNING: This product contains a chemical

known to the State of California to cause cancer.

For consumer products that contain a reproductive toxicant, the following language is

provided:

WARNING: This product contains a chemical

known to the State of California to cause birth

defects or other reproductive harm.

Do not use the carcinogen warning if the product contains only a reproductive toxicant.

Similarly, do not use the reproductive toxicant warning if the product contains only a

carcinogen. If the product contains both a carcinogen and a reproductive toxicant, use

both warnings. If you combine the warnings and say that the product contains a

chemical known to the State to cause cancer “or” birth defects or other reproductive

harm, the warning may be deemed ineffective. You may combine the warning where the

same chemical is both a carcinogen and a reproductive toxin. In that case the following

warning can be used:

WARNING: This product contains a chemical

known to the State of California to cause cancer

and birth defects or other reproductive harm.

Occupational exposures. Occupational exposures are defined by the

regulations as “an exposure, in the workplace of the employer causing the

exposure, to any employee.” 22 CCR § 12601(c). Occupational exposures do not

include exposures to visitors to the workplace or to persons residing near the

workplace. Although the Proposition 65 regulations provide safe harbor warning

methods and messages for occupational exposures, the California HCS applies

as a result of federal preemption by the federal HCS. The California HCS

requires an employer to comply with the California HCS as the method to comply

with Proposition 65 where the chemical exposure involved is subject to both the

California HCS and Proposition 65. Where the chemical exposure is not

otherwise subject to the California HCS, the employer can comply with either the

California HCS or the Proposition 65 safe harbor warnings for occupational

exposures.

Page 11: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

10

Alternative safe harbor warning methods and messages for occupational

exposures include:

• Labels on products used in the workplace that carry the messages in the

manner set forth above for consumer product warnings.

• Signs posted conspicuously in the affected areas of the workplace with one

or both of the following messages:

WARNING: This area contains a chemical known

to the State of California to cause cancer.

WARNING: This area contains a chemical known

to the State of California to cause birth defects or

other reproductive harm.

• Full compliance with all information, training and labeling requirements of the

federal Hazard Communication Standard, 29 CFR § 1910.1200, the California

Hazard Communication Standard (which now incorporates the Proposition 65

requirements), 8 CCR § 5194, or if applicable, the Pesticides and Worker

Safety requirements, 3 CCR § 6700 et seq.

Environmental exposures. All exposures that are not occupational or consumer

product exposures are considered to be environmental exposures. Environmental

exposures are generally defined as exposures “which may foreseeably occur as

the result of contact with an environmental medium, including, but not limited to,

ambient air, indoor air, drinking water, through inhalation, ingestion, skin contact,

or otherwise.” 22 CCR § 12601(d). The exposure of nearby residents to air

pollutant emissions from manufacturing facilities and exposures to customers or

other visitors at distribution facilities are examples of potential environmental

exposures.

In order to be effective, an environmental exposure warning must be likely to be

read, seen or heard and understood by an ordinary individual in the course of

normal activity. 22 CCR § 12601(d)(2). In order to rely upon a “safe harbor”

warning for environmental exposures, you should use the most appropriate of the

following alternative methods:

• Posting signs in the affected area. For potential exposures to agricultural

chemical applications, signs posted in the manner described in Department of

Page 12: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

11

Pesticide Regulation at 3 CCR § 6776(e)(1) are an appropriate method of

warning. 22 CCR § 12601(d)(1)(A).

• A notice mailed or otherwise delivered to each occupant in the affected area

at least once every three months during the period of exposure. No safe

harbor warning message is provided in the regulations for this type of

warning. 22 CCR § 12601(d)(1)(C).

• A warning provided by public media announcements that target the affected

area at least once every three months during the period of exposure. No safe

harbor warning message is provided in the regulations for this type of

warning. 22 CCR § 12601(d)(1)(D).

The form and content of media announcements and published notices have been the

subject of much litigation. You should consult counsel before choosing one or more

of the three “safe harbor” methods for environmental exposure warnings.

Page 13: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

12

Assessing Compliance

Assessing the state of your company’s compliance with Proposition 65 is not likely to

be a simple matter. Nevertheless, the general steps to follow are outlined below.

Please note: The following approach does not attempt to cover all aspects of any individual company’s Proposition 65 compliance. If you have questions about whether Proposition 65 applies to your products or how to comply with it, you may wish to consult legal counsel.

Step 1: Does Proposition 65 Apply to You?

Are you doing business? Unless you are a local, state or federal governmental

entity or a public water system, for purposes of Proposition 65 you probably are

doing business. “Business” is defined very broadly. It includes not-for-profit activities

and any activities of your employees that further the purposes or operation of the

business. 22 CCR § 12102(k).

Do you have 10 or more employees? The number of your employees includes all of

the persons who are employees for purposes of Unemployment Insurance

Code § 621 and Labor Code § 3351. Be sure to count all full-time and part-time

employees, including seasonal employees and contract laborers. You may also need

to count commissioned sales persons depending on their arrangements with you.

22 CCR § 12102(h). If the number of your employees changes from time to time,

remember that the number of employees you have on the day of exposure or the day

of discharge is the number that counts, not the number you ordinarily employ. If you

count 10 or more employees, then read on. If not, then be sure to check again as

your business grows.

Are you an out-of-state manufacturer? If you are an out-of-state manufacturer of

an industrial product intended for use solely in the workplace, then the Proposition

65 warning requirement for workplace exposures does not apply to you. The federal

HCS preempts Proposition 65, except to the extent incorporated into the California

State Plan. The State Plan applies only to manufacturers, distributors and employers

operating within the State. If your product may expose individuals outside the

workplace, however, then you are subject to Proposition 65 and may have a warning

obligation with regard to the non-workplace exposures.

Page 14: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

13

Are you an in-state distributor? If you are a distributor of an industrial use product,

then it appears that you are not required to provide independent Proposition 65

warnings to downstream customers. Instead, you are required to provide downstream

customers with copies of the Material Safety Data Sheets (“MSDS”) and labels

prepared by the manufacturer. Nevertheless, OSHA has recognized that in some

cases, an in-state distributor can become a “manufacturer” subject to Proposition 65

by engaging in certain in-state conduct, such as re-packaging the product, re-

formulating the product, or mixing chemicals. In that case, you may be required to

comply with the California HCS as an in-state manufacturer. Of course, all in-state

employers are subject to the California HCS.

Step 2: Identify Listed Chemicals

Whether you are concerned about exposures, discharges or releases, the next step

is to determine whether your business activities in the State of California, including

any products or services you sell in California, involve or contain any Proposition 65

listed chemicals. The most recently issued list of Proposition 65 chemicals available

at the time of publication are set forth in the Proposition 65 regulations. The current

list of regulations is available on the OEHHA web site at www.oehha.org.

For a product, you should identify all chemicals in the product, including the

packaging. For services, consider all chemicals used in providing the service. If you

maintain a workplace in California, identify all of the chemicals that you handle in the

workplace. Then check the Proposition 65 list to see whether any of your chemicals

are on the list. Note that the list is updated frequently, so your compliance program

must be ongoing.

If your product (plus packaging), services, or other activities do not involve any listed

chemicals, that will likely complete your Proposition 65 compliance program for now.

Proposition 65 only applies to listed chemicals. But if you have identified a listed

chemical, read on.

Page 15: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

14

Step 3: Identify “Exposures” and “Discharges”

Exposures. The next step is to determine whether your handling of a listed chemical

or the foreseeable use of your product or service will expose anyone to the listed

chemical. With regard to a California workplace, you should determine whether there

are any potential exposures to employees in your workplace or other persons who

may reside or work near your workplace or other business activities. Typical routes

of exposure include inhalation, skin absorption and ingestion.

Discharges. For purposes of the discharge prohibition, the question is a little

different: whether the discharged chemical passes or probably will pass into a source

of drinking water. Chemicals discharged to air or land may find their way into a

source of drinking water. Similarly, chemicals released from a product, such as a

faucet or a pipe, may pass into tap water, which is considered a source of

drinking water.

Step 4: Determine Level of Exposure or Discharge

Exposures. Once you have identified potential exposures to a listed chemical,

determine whether any exposures require a warning.

Discharges. Similarly, if you have identified a potential discharge or release of a

listed chemical that is likely to enter a source of drinking water, the next step is to

determine whether the chemical will enter the source of drinking water in a

“significant amount.”

In some instances you may know, without need for additional measurement, that the

exposure is so far above or below the Proposition 65 exposure criteria that you need

not dwell on this step. In other instances you may need to perform an assessment of

the level of exposure involved. 22 CCR §§ 12721, 12821. Similarly, you may need to

evaluate further whether the discharge or release may enter drinking water in a

significant amount. To do this, you must determine whether the amount would

exceed the Proposition 65 exposure criteria if a person were exposed to the amount

in drinking water.

Page 16: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

15

Step 4a: Carcinogens: Determine Whether Exposure or Discharge is Below the

“No Significant Risk Level”

The Proposition 65 warning requirement for exposure to a carcinogen does not apply

if the exposure poses “no significant risk.” The discharge prohibition does not apply if

the amount of listed chemical that will likely enter a source of drinking water will pose

“no significant risk” if a person were exposed to that amount in drinking water. “No

significant risk” is defined as a risk of fewer than one excess case of cancer in an

exposed population of 100,000 assuming a lifetime exposure at the level in question.

The State has established regulatory levels that are deemed to pose “no significant

risk” for some listed carcinogens. 22 CCR § 12705. This list is updated from time

to time.

For carcinogens without a regulatory level, the regulations provide methods for

performing a risk assessment to determine whether the exposure would pose “no

significant risk.” See 22 CCR §§ 12701, 12721.

Step 4b: Reproductive Toxicants: Determine Whether Exposure or Discharge

is 1,000 Times Less than the “No Observable Effect Level”

The Proposition 65 warning requirement for exposure to a reproductive toxicant does

not apply if the exposure “will have no observable effect assuming exposure at one

thousand (1,000) times the level in question.” Similarly, the discharge prohibition

does not apply if the amount of listed chemical that will likely enter a source of

drinking water “will have no observable effect assuming exposure at one thousand

(1,000) times the level in question” if a person were exposed to that amount in

drinking water.

The State has established regulatory levels for certain reproductive toxicants.

22 CCR § 12805. If the level of exposure does not exceed the regulatory level,

then no Proposition 65 warning is needed and you have not violated the discharge

prohibition. But note that the State may update these levels from time to time.

For reproductive toxicants without a regulatory level, the regulations provide

methods for establishing a no observable effect level. 22 CCR §§ 12801 and 12803.

Page 17: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

16

Step 5: Compliance

The result of your analysis will be a determination regarding whether a warning is

required or whether a discharge is prohibited under Proposition 65. Each

determination presents a different set of alternatives.

Step 5a: Complying with the Warning Provision

If you are exposing Californians to a listed chemical at levels that exceed the

Proposition 65 exposure criteria, then Proposition 65 requires you to provide a “clear

and reasonable” warning prior to the exposure. As discussed above, the warning

must clearly communicate that the chemical in question is known to the State to

cause cancer, or birth defects or other reproductive harm.

One other alternative, which many companies have found attractive, is to reformulate

the product or discontinue use of the listed chemical in providing services or in

manufacturing processes. The goal is to eliminate or reduce exposures to a level

below the exposure criteria and thus avoid the need to provide a Proposition 65

warning.

Step 5b: Complying with the Discharge Prohibition

If you are discharging or releasing a chemical in an amount that is likely to enter a

source of drinking water in a “significant amount,” the final compliance steps are not

so simple. Issuing a warning will not bring you into compliance with Proposition 65.

Instead, you must cease the discharge, either by revising the process or activity that

produces, discharges or releases the listed chemical or by discontinuing use of the

chemical.

Page 18: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

17

A Final Word

Complying with Proposition 65 is not a simple matter. The regulations under

Proposition 65 have far more nuances than can be explained in this brief

introduction. In addition, the law is not static. Only a few of its terms have been

addressed by the courts. Proposals to change the statute and regulations are under

recurring consideration. Public enforcers, environmental groups and “bounty hunters”

are bringing increasing numbers of suits. More chemicals will undoubtedly be listed.

Thus, it is important that you continue to pay close attention to the developing law of

Proposition 65 and seek the advice and assistance of experienced counsel in

addressing your company’s compliance with Proposition 65. For additional

information or assistance, please contact Trenton H. Norris.

Page 19: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

18

Trenton H. Norris Trent Norris, a partner in the San Francisco office of Bingham McCutchen, is

recognized as a leader among the handful of most experienced Proposition 65

lawyers. In his 12 years of experience with the law, he has represented over 100

companies – large and small – in Proposition 65 litigation and compliance matters.

Mr. Norris has published numerous articles and regularly speaks to trade

associations and clients about Proposition 65 developments. From 2002 to 2004, he

served as Chair of the Editorial Advisory Board of Prop 65 News. He has served on

the Advisory Board of the Prop 65 Clearinghouse since its inception in 2004. In the

2004 election campaign, he served as a volunteer spokesperson for the "Yes on 64"

campaign that resulted in reforms of the state's Unfair Business Practices Act that

have reined in frivolous litigation against companies doing business in California.

Mr. Norris's clients are primarily manufacturers, distributors and retailers of everyday

products. His cases have involved diverse products, technologies and industries,

including water meters, plumbing valves, bottled water, dandruff shampoo, well

pumps, power tools, medical devices, light bulbs, herbal remedies, aquarium

additives, crystal glassware, soft drinks, vaccines, home electronics, paints,

detergents, building materials, dietary supplements, snack chips, motor vehicles,

pharmaceuticals, batteries and hospital sterilization equipment. Given this variety,

Mr. Norris is also experienced in the interplay between Proposition 65 and

other legal requirements such as the food and drug laws, false advertising laws, and

consumer protection laws. In addition to these areas, Mr. Norris also

represents consumer product and service companies in product liability and

intellectual property matters.

Mr. Norris received his degrees magna cum laude from Brown University (A.B. 1986)

and Harvard University (J.D. 1992), where he was an editor of the Harvard Law

Review. Before attending law school, he served as the top legislative aide to a

United States Senator on environmental matters.

Bingham McCutchen LLP Three Embarcadero Center San Francisco, CA 94111 (415) 393-2000 (415) 393-2286 (fax) [email protected]

Page 20: California’s Proposition 65: A Guidebook and Resource · 2 Overview California’s Safe Drinking Water and Toxic Enforcement Act of 1986 is commonly referred to as “Proposition

Boston

Hartford

London

Los Angeles

New York

Orange County

San Francisco

Silicon Valley

Tokyo

Walnut Creek

Washington

bingham.com

©2006 Bingham McCutchen LLP

To communicate with us regarding protection of your personal information or if you would like to subscribe or unsubscribe to some or all of Bingham McCutchen LLP’s electronic and mail communications, please notify our Privacy Administrator at [email protected] or [email protected]. Our privacy policy is available at www.bingham.com/privacy.asp. We can also be reached by mail in the U.S. at 150 Federal Street, Boston, MA 02110-1726, ATT: Privacy Administrator, or in the U.K. at 41 Lothbury, London, England EC2R 7HF, ATT: Privacy Administrator.

This communication is being circulated to Bingham McCutchen LLP’s clients and friends and may be considered advertising. It is not intended to provide legal advice addressed to a particular situation.